{ "schema_version": "chamgap-public-criteria-1.0", "title": "Wall-sit training × medication replacement and cardiovascular events: directly untested", "language": "en", "translation_date": "2026-10-18", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Some information is present in the stored source, with detailed original materials still unverified; this does not mean review passed or clinical efficacy certified", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Awaiting user review", "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which treatment-replacement and event-prevention claims are selected?", "needed": "Exact medication-replacement and cardiovascular-event claims and original grade", "role": "Required", "role_reason": "This condition connects Exact medication-replacement and cardiovascular-event claims and original grade with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Exact medication-replacement and cardiovascular-event claims and original grade must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct materials identifying each treatment-replacement and clinical-event question. Do not turn ? into no effect, 0 points or no studies at all. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Was medication replacement tested directly?", "needed": "Direct comparative medication-replacement results", "role": "Required", "role_reason": "This condition connects Direct comparative medication-replacement results with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Direct comparative medication-replacement results must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Clear medication comparison, treatment-replacement endpoints, stability, rescue treatment and long-term follow-up. No medication-change instructions are written. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is there comparative evidence of equivalence to medication?", "needed": "Direct active-medication comparison and equivalence/noninferiority design", "role": "Required", "role_reason": "This condition connects Direct active-medication comparison and equivalence/noninferiority design with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Direct active-medication comparison and equivalence/noninferiority design must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct medication control, prospective equivalence/noninferiority margins, analysis populations, CIs and actual treatment conditions. Null P values or SBP reductions do not establish medication equivalence. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Was the key trial about reducing existing medication?", "needed": "Distinguishing untreated participants from people changing existing treatment", "role": "Required", "role_reason": "This condition connects Distinguishing untreated participants from people changing existing treatment with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Distinguishing untreated participants from people changing existing treatment must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Baseline/follow-up medication status, eligibility and cointerventions. Preserve population context without writing reduction/discontinuation instructions. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Were cardiovascular clinical events measured directly?", "needed": "Event-specific cardiovascular-prevention results", "role": "Required", "role_reason": "This condition connects Event-specific cardiovascular-prevention results with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Event-specific cardiovascular-prevention results must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Event types, definitions, adjudication, arm events, time at risk, follow-up and competing events. Untested does not mean 0 events or a prevention effect of 0. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Is reduced SBP a direct event-prevention result?", "needed": "Distinguishing resting-SBP surrogates from clinical events", "role": "Required", "role_reason": "This condition connects Distinguishing resting-SBP surrogates from clinical events with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Distinguishing resting-SBP surrogates from clinical events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct event comparisons and surrogate-to-event links for the relevant population/duration. No new risk-reduction calculations or hypothetical numerical examples. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How does the null DBP result differ from the clinical questions?", "needed": "Separating DBP results from treatment-replacement/event-prevention questions", "role": "Required", "role_reason": "This condition connects Separating DBP results from treatment-replacement/event-prevention questions with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Separating DBP results from treatment-replacement/event-prevention questions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Separate direct treatment-replacement/event materials and DBP analysis tables. Preserve endpoint-specific questions and unverified scope. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What does the small 4-week sham trial support?", "needed": "Directness boundaries of Decaux pressure results", "role": "Required", "role_reason": "This condition connects Directness boundaries of Decaux pressure results with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Directness boundaries of Decaux pressure results must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual endpoint hierarchy, medication/event materials and separate direct-question evidence. Short-term pressure support is not counted as independent event-prevention replication. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Do initial and maintenance phases establish long-term event prevention?", "needed": "Duration boundaries of initial training and later pressure maintenance", "role": "Required", "role_reason": "This condition connects Duration boundaries of initial training and later pressure maintenance with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Duration boundaries of initial training and later pressure maintenance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Phase-specific populations, denominators, actual event follow-up, losses and treatment replacement. Pressure maintenance is not extended into long-term clinical efficacy. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are analysis denominators available for events and treatment replacement?", "needed": "Distinguishing pressure samples from event/medication endpoint denominators", "role": "Required", "role_reason": "This condition connects Distinguishing pressure samples from event/medication endpoint denominators with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Distinguishing pressure samples from event/medication endpoint denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Arm analysis denominators, time at risk, missingness, withdrawals and original event tables for direct endpoints. Do not add the reports' n values. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are cointerventions and rescue treatments verified?", "needed": "Medication, other exercise, lifestyle changes and actual controls", "role": "Required", "role_reason": "This condition connects Medication, other exercise, lifestyle changes and actual controls with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Medication, other exercise, lifestyle changes and actual controls must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Cointerventions, rescue treatment, adherence, intervention departures and treatment-change records. Leave these as material needs without medication-change instructions. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Were event prevention and medication replacement prospective endpoints?", "needed": "Prospective status and analysis plans for direct clinical endpoints", "role": "Required", "role_reason": "This condition connects Prospective status and analysis plans for direct clinical endpoints with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Prospective status and analysis plans for direct clinical endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original timing, amendment history, prospective clinical endpoints and analysis plans in registration, protocols and SAPs. External registration/plans were not read this time. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Do 0 reported adverse events establish cardiovascular protection?", "needed": "Separating harm collection from cardiovascular-event prevention", "role": "Required", "role_reason": "This condition connects Separating harm collection from cardiovascular-event prevention with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Separating harm collection from cardiovascular-event prevention must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Harm definitions, collection, arm exposure, denominators, actual event adjudication and long-term follow-up. 0 reports do not establish no harm or cardiovascular protection. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What materials would answer the direct clinical questions?", "needed": "Separate direct evidence for medication replacement and event prevention", "role": "Required", "role_reason": "This condition connects Separate direct evidence for medication replacement and event prevention with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Separate direct evidence for medication replacement and event prevention must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual direct medication comparisons, endpoints, CIs and adequate clinical-event follow-up, denominators and definitions. Record needed materials without new research, independence certification or treatment instructions. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are shared reports being counted as new trials?", "needed": "Links among reports, trials and selected questions", "role": "Required", "role_reason": "This condition connects Links among reports, trials and selected questions with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Links among reports, trials and selected questions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report, cohort and analysis-population identifiers and shared relationships. No new unique-trial/participant totals or independent-replication certification. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Which materials were actually read?", "needed": "Distinguishing stored summaries from external originals", "role": "Required", "role_reason": "This condition connects Distinguishing stored summaries from external originals with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Distinguishing stored summaries from external originals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actually acquired originals, supplements and access records. A URL or historical verification statement does not become current full-text reading or a met condition. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Where are bibliographies and registration identifiers recorded?", "needed": "Report-specific bibliographic/registration locations", "role": "Required", "role_reason": "This condition connects Report-specific bibliographic/registration locations with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Report-specific bibliographic/registration locations must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Paper/registration identities, dates and material links. Do not infer new URLs from identifiers or claim registration contents were verified. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "How are original languages and historical verification statements preserved?", "needed": "Original Korean/English wording, selected-claim notes and historical scope", "role": "Required", "role_reason": "This condition connects Original Korean/English wording, selected-claim notes and historical scope with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Original Korean/English wording, selected-claim notes and historical scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Review of originals, translations and corrections. Historical verification wording is not relabeled as passing current review. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are selected-question grades/axes separate from the parent verdict?", "needed": "Selected original grade, absent score and parent context", "role": "Required", "role_reason": "This condition connects Selected original grade, absent score and parent context with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Selected original grade, absent score and parent context must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Review of selected-question boundaries/content. No new scoring, axis changes or copying of parent scores. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What are the evidence date and correction records?", "needed": "Distinguishing the original date and empty records from production", "role": "Required", "role_reason": "This condition connects Distinguishing the original date and empty records from production with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Distinguishing the original date and empty records from production must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Latest corrections, follow-up materials and original histories. No arbitrary new evidence date, correction or verdict value. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are funding, product support, employee authors and analysis involvement distinguished?", "needed": "Report-specific funding and company-related items", "role": "Required", "role_reason": "This condition connects Report-specific funding and company-related items with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Report-specific funding and company-related items must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report-specific funding, support, affiliations and analysis/publication-role originals. Unprovided funding does not mean no company; parent I2 is not newly certified. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are allocation, blinding and pressure-measurement bias materials available?", "needed": "Allocation, measurement and selective reporting", "role": "Required", "role_reason": "This condition connects Allocation, measurement and selective-reporting conditions with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Allocation, measurement and selective reporting must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Methods, protocols, SAPs, original measurements and amendment histories. A design label does not establish formal RoB/GRADE or passed review. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are study conditions separate from actual delivery and cointerventions?", "needed": "Intervention identification versus actual exposure", "role": "Required", "role_reason": "This condition connects Intervention identification versus actual exposure with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Intervention identification versus actual exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual arm exposure, departures, cointerventions and analysis effects. No execution procedures, intensity-setting methods or medication reduction/replacement instructions. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are acute in-exercise pressure and resting results distinguished?", "needed": "Separate acute timing and report identity", "role": "Supplementary", "role_reason": "This condition connects Separate acute timing and report identity with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Separate acute timing and report identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Acute-study originals, populations, denominators, timing, exposure and links to resting results. Acute values do not create long-term harm rates, event-prevention effects or exercise instructions. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What is the scope of 0 reported adverse events?", "needed": "Harm collection, exposure and arm denominators", "role": "Supplementary", "role_reason": "This condition connects Harm collection, exposure and arm denominators with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Harm collection, exposure and arm denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Harm definitions, collection, arm exposure/denominators, withdrawals and original severity tables. 0 reports do not establish complete safety or no harm. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are long-term/rare harms and post-training effects known?", "needed": "Short-term/maintenance versus long-term clinical/harm boundaries", "role": "Supplementary", "role_reason": "This condition connects Short-term/maintenance versus long-term clinical/harm boundaries with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Short-term/maintenance versus long-term clinical/harm boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual long-term follow-up, harm surveillance, endpoint denominators and matching interventions/populations. Short reports or parent caution do not create new long-term safety/efficacy certification. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What would trigger an update?", "needed": "Original material, conditions, observations and verdict changes", "role": "Required", "role_reason": "This condition connects Distinguishing source, condition, observation and verdict changes with directly untested medication replacement/equivalence and cardiovascular-event prevention, blood-pressure surrogates, and population, denominator, duration and harm boundaries.", "application_exception": "Preserve selected original grade ? and the directly untested note. Distinguish absent subclaim score/status/axes from parent grade C with 54 points. Untested does not mean 0 events, an effect of 0 or no studies at all. Create no new effects, CIs, totals, grades, independence/safety certification or exercise, breathing, medication or treatment instructions.", "criterion": "Material for Original material, conditions, observations and verdict changes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: New originals, complete pre-change copies, condition versions, application events and review records. Distinguish material registration from content/verdict changes. This records needed materials; no new research was executed." } ] }